Cleanrooms aren’t defined as having zero pollutants in the air, but are instead classified according to how “clean” the air in the room must be in order for the room to be acceptable. United Maintenance, Inc. will design and install your room to meet or exceed whichever cleanroom classification your business requires.
Federal Standard 209e and ISO Standard 1446
Cleanroom classifications define the size and number of particulates that are allowable per cubic foot of air. There are several standards or guidelines in place by which we test and monitor the interior environment to make sure the particulates in the air do not exceed a certain number. The older standard is U.S. Federal Standard 209e (or FS209e), which measures particles that are 0.5 microns or larger per cubic foot. However, newer guidelines have recently been introduced by the International Organization for Standardization (ISO 1446), which measures the number of particles per cubic meter. Each standard helps us determine how clean the air is, and how clean the air needs to be. UMI builds all its cleanrooms to meet or exceed these standards.
| Class | Maximum Particles / m³ | U.S. Federal Standard 209E Equivalent |
|||||
| ≥0.1 µm | ≥0.2 µm | ≥0.3 µm | ≥0.5 µm | ≥1 µm | ≥5 µm | ||
| ISO 1 | 10 | 2 | |||||
| ISO 2 | 100 | 24 | 10 | 4 | |||
| ISO 3 | 1,000 | 237 | 102 | 35 | 8 | Class 1 | |
| ISO 4 | 10,000 | 2,370 | 1,020 | 352 | 83 | Class 10 | |
| ISO 5 | 100,000 | 23,700 | 10,200 | 3,520 | 832 | 29 | Class 100 |
| ISO 6 | 1,000,000 | 237,000 | 102,000 | 35,200 | 8,320 | 293 | Class 1000 |
| ISO 7 | 352,000 | 83,200 | 2,930 | Class 10,000 | |||
| ISO 8 | 3,520,000 | 832,000 | 29,300 | Class 100,000 | |||
Cleanroom Classifications for Compounding Pharmacies (USP 797)
Compounding pharmacies have their own special cleanroom requirements to meet, which are defined by Federal Standard 797 (or USP 797). UMI is able to meet and exceed these standards as well, building your room to specifications and monitoring the air to keep your pharmacy cleanroom in compliance with federal regulations.
Current Good Manufacturing Practices (CGMP)
UMI also stays aware of established federal guidelines on current good manufacturing and material handling practices (CGMPs), and stays well within these guidelines during the installation process of your cleanroom to ensure that the room does not become contaminated or compromised as a result of the installation itself.
Architectural Finish Standards
The actual materials used in your cleanroom are a key factor in maintaining its classification requirements. United Maintenance will assess your cleanroom needs and advise you on your architectural options for construction, including wall and flooring materials, lighting, filtering, ionization, air showers, pass-throughs, particle counting systems and more.